DOC NO P-11

PROCEDURE MANUAL
REV NO 01
ISSUE DATE 01.04.2017
INTERNAL QUALITY AUDIT
PAGE 1 of 4

PURPOSE:
This procedure defines the method for planning & implementing Internal Quality Audits to:
* Verify whether Quality activities & related results comply with the documented Quality system.
* Determine the effectiveness of the Quality System.
* Determine effectiveness of Manufacturing process

SCOPE:
This procdeure covers all working shifts in all areas of organization

RESPONSIBILITY:

a) Management representative is responsible for scheduling and conducting internal audits within the plant. The audit
schedules are prepared based on the importance and the status of the activity to be audited.

b) The internal audit team consists of qualified and trained personnel. The auditors, who are independent of the activities
being audited, conduct audits. The MR is at liberty to use external help, professionals in conducting internal audits. MR shall
maintain a list of approved internal auditors.

PROCEDURE:
* System Audit Process Map
* Manufacturing Process cum Product Audit process Map

Note:
The audit observations for internal audit process are categorized as follows:

OBS (+ or -) = Observation Positive or Negative

OI = Opportunities for Improvement.

NC = Non Conformity Report

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DOC NO P-11
PROCEDURE MANUAL
REV NO 01
ISSUE DATE 01.04.2017
INTERNAL AUDIT (SYSTEM AUDIT)
PAGE 2 of 4
Responsibility ACTIVITY
(Ref Doc No)
.1
.Prepare Annual Audit Plan
MR
IPC/MR/07

Discuss with internal auditors for areas to be audited .2

at least once in six months according to the internal
MR audit schedule
IPC/MR/08

.3
Notify Auditor(s) & Auditee(s) about time , date & scope of audit according to
MR internal audit program

.4
Before audit , review all applicable docuemntation & previous non
conformity reports for corrective action for the areas being audited
Auditor

.5
Auditor Conduct audits of the assigned area /department
. as per check list
IPC/MR/09 No

Auditor Verify effective implementation of closed .6

corrective(s) of previous NC report of that area
IPC/MR/10

Record respective Audit observation .7

Auditor

Any Discrepency.6
found in
NO .7
Auditor documentation or Record positive findings/ strength
during the audit

Yes

Auditor ..8
IPC/MR/10 Note Descrepencies in Non Conformity report

A
 A

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DOC NO P-11
PROCEDURE MANUAL
REV NO 01
ISSUE DATE 01.04.2017
INTERNAL AUDIT (SYSTEM AUDIT)
PAGE 3 of 4
Responsibility ACTIVITY
(Ref Doc No)

.9
Prepare NCR summary & forward copy to Managment
Auditor representative

IPC/MR/11

.10
Auditor Issue non- conformity report (if any ) & observation of auditor to auditee

.11
Follow up Audit to verify implementation & effectivness of corrective
MR
action

MR Prepare NCR summary report for MR meeting .12

IPC/MR/11

.13
Update & File Internal audit reports
MR
PREPARED BY APPROVED BY

Procedure No. P-11

PROCEDURE MANUAL
REV NO 01
ISSUE DATE 01.04.2017
INTERNAL QUALITY AUDIT
( MANUFACTURING PROCESS Cum PRODUCT
AUDIT )
PAGE 4 of 4
Responsibility ACTIVITY
(Ref Doc No)
.1
MR Prepare Annual Audit Plan covering all shift , Manufacturing Process
. cum Product Process at least once in Six months
IPC/QA/18

.2
MR Prepare check points for Manufacturing Process cum
Product Audit In Accordance to Control Plan
IPC/QA/18A

.3
Inform to Qualified Auditors & Auditees(Shift Incharge) in advance for Audit
MR .Schedule Program

Auditor .4
Conduct Process & Product audit as per audit checklist
IPC/QA/18A

.5 .6
Auditor Any No
Record positive findings/ strength
IPC/QA/18A Discrepency

Yes
Auditor .7
Raise Nonconformity on Check Sheet and take
IPC/QA/18 concern of auditee

.8
Auditee Auditees to propose/initiate short term/ long term corrective action

.9
Close the Non Conformity after verificationof Closure of NonConformity
Auditor
 Close the Non Conformity after verificationof Closure of NonConformity

IPC/QA/18A

.10
MR Prepare Manufacturing Process cum Product Audit summary for
Management review

.11
MR File/ maintain records

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